I need to add the following to clarify my below statements regarding FDA certification.
21CFR, Chapter I, Section 1002.1(b) allows exemption for components intended for sale exclusively to other manufacturers for use in other products. The implication is that, if the component might be sold through a retail or wholesale supplier to other than manufacturers (the public, educational institutions, etc), the component must be certified. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina Homologation Services peter.tar...@sanmina.com > -----Original Message----- > From: Tarver, Peter [SC1:9031:EXCH] > Sent: Wednesday, January 10, 2001 12:47 PM > > Hi, KB. > > It is incorrect that IEC825 does not apply to components. In > the case of components, the worst case emissions, based on > power supply and any other factors that affect output > power/energy must be considered. > > The FDA requirements in 21CFR requires all laser sources, > devices or products to be certified. > > Regards, > > Peter L. Tarver, PE > Product Safety Manager > Sanmina Homologation Services > peter.tar...@sanmina.com > > > > -----Original Message----- > > From: k...@i-data.com [mailto:k...@i-data.com] > > Sent: Tuesday, January 09, 2001 11:58 PM > > > > Hi all, > > > > I have been asked if a laser which will be sold as a > > component will have to > > be FDA approved. IEC 825 does not include lasers which are > > components, only > > end-user products. > > > > I can't understand the FDA requirements concerning components. > > > > The laser is a Class 3B laser > > > > Please send me a clear simple answer, if anybody can. > > > > K. B. Jensen > > >
